Cognitive and Physical Stimulation and Promotion of Social Relations for the Benefit of Older People's Quality of Life (StimCoAPS)

March 24, 2025 updated by: University of Poitiers

Effect of Practice Environment on Perceived Benefits of Combined Physical and Cognitive Program on Older People's Cognitive Abilities and Quality of Life

The aim of this interventional study is thus to assess and highlight the cognitive, physical, and psychosocial benefits of a combined physical and cognitive training program in an enriched environment and to assess the factors influencing these benefits.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The number of older people worldwide is constantly increasing. However, one of the main problems associated with aging is cognitive decline, which affects essential everyday functions such as memory, attention, and executive functions. Thus, maintaining autonomy and quality of life depends on physical health, and the integrity of cognitive functioning. Cognitive, physical and social activities can all slow this decline but social factors and their contribution to the well-being of older people remain under-researched. The aim of the present study is to analyze how the practice environment can foster these social relations and thus enhance wellbeing and to identify the psychological dimensions that are activated by social relations.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
172

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Poitiers, France, 86000
        • University of Poitiers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • People must be at least 65 years old
  • People must be at independent (able to get around on their own: car, bus, walking)
  • People must be at living in the community (not in an institution such as a nursing home)
  • The persons recruited must have a score on the Montreal Cognitive Assessment (MoCA) of at least 18.

Exclusion Criteria:

  • People with contraindications for engaging in regular physical activity
  • People with severe neurological and psychological disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Individual practice at home
Participants will undergo a training program combining physical and cognitive activities in individual practice at home.
Other: Combined physical and cognitive program
All participants will complete 12-week training sessions combining physical and cognitive activities, with two 1-hour sessions per week.
Experimental: Group practice in a traditional group environment (gymnasium)
Participants will undergo a training program combining physical and cognitive activities in group practice in a traditional group environment (gymnasium).
Other: Combined physical and cognitive program
All participants will complete 12-week training sessions combining physical and cognitive activities, with two 1-hour sessions per week.
Experimental: Group practice in an enriched environment fostering social relations
Participants will undergo a training program combining physical and cognitive activities in group practice in an enriched environment fostering social relations.
Other: Combined physical and cognitive program
All participants will complete 12-week training sessions combining physical and cognitive activities, with two 1-hour sessions per week.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline Score at Trail Making Test (TMT)
Time Frame: inclusion; 6 weeks; 12weeks; 9 months
Score at cognitive flexibility function. higher scores mean a worse outcome.
inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at Stroop task
Time Frame: inclusion; 6 weeks; 12weeks; 9 months
Score at cognitive inhibition function. higher scores mean a worse outcome.
inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at N-Back task
Time Frame: inclusion; 6 weeks; 12weeks; 9 months
Score at working memory updating. Higher scores mean a better outcome
inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at Montreal Cognitive Assessment (MoCA)
Time Frame: inclusion; 6 weeks; 12weeks; 9 months
Score at basic cognitive functions. Higher scores mean a better outcome
inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at letter comparison test (XO test)
Time Frame: inclusion; 6 weeks; 12weeks; 9 months
Score at processing-speed of information. Higher scores mean a better outcome
inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at Remember-Know paradigm
Time Frame: inclusion; 6 weeks; 12weeks; 9 months
Score at episodic memory. Higher scores mean a better outcome
inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at 16-item Free and Cued Recall
Time Frame: inclusion; 6 weeks; 12weeks; 9 months
Score at episodic memory. Higher scores mean a better outcome
inclusion; 6 weeks; 12weeks; 9 months
Score at Mill-Hill vocabulary test
Time Frame: Inclusion
Score at crystallized intelligence. Higher scores mean a better outcome
Inclusion
Change from baseline Score at Social Provisions Scale [SPS-10; score: 10-40]. (self-report questionnaire)
Time Frame: inclusion; 6 weeks; 12weeks; 9 months
Perceived social support Score (attachment, social integration, confirmation of one's value, material help, orientation) (self-assessment). Higher scores mean a better outcome.
inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at Rosenberg's Self-Esteem Scale [EES-10; score: 10-40] (self-report questionnaire)
Time Frame: inclusion; 6 weeks; 12weeks; 9 months
Perceived self-esteem Score (self-assessment). Higher scores mean a better outcome.
inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at French Achievement Goals Questionnaire for Sport and Exercise (QFBASEP) (self-report questionnaire)
Time Frame: inclusion; 6 weeks; 12weeks; 9 months
Goal of motivation for physical activity (self-assessment)
inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at 5-item World Health Organization well-being index [WHO-5; score: 0-100] (self-report questionnaire)
Time Frame: inclusion; 6 weeks; 12weeks; 9 months
Perceived well-being Score (self-assessment). Higher scores mean a better outcome.
inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at Mental Health Continuum Short Form [MHC-SF; score: 0-70] (self-report questionnaire)
Time Frame: inclusion; 6 weeks; 12weeks; 9 months
Perceived emotional, social and psychological well-being Score (self-assessment). Higher scores mean a better outcome.
inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at anxiety item on Hospital Anxiety and Depression Scale [HADS; score: 0-21] (self-report questionnaire)
Time Frame: inclusion; 6 weeks; 12weeks; 9 months
Anxiety Score (self-assessment). higher scores mean a worse outcome.
inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at depression item on Hospital Anxiety and Depression Scale [HADS; score: 0-21] (self-report questionnaire)
Time Frame: inclusion; 6 weeks; 12weeks; 9 months
Depression Score (self-assessment). higher scores mean a worse outcome.
inclusion; 6 weeks; 12weeks; 9 months
Semi-structured interview
Time Frame: inclusion; 6 weeks; 12weeks; 9 months
Assessment of social and cultural life, and assessment of interactions and relations with group members or teachers: "How would you describe your social and cultural life now?", "How the sessions with the other members of the group going?"
inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at level of physical activity and sedentary lifestyle questionnaire (ONAPS)
Time Frame: inclusion; 6 weeks; 12weeks; 9 months
Level of physical activity and sedentary lifestyle
inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at Dynamic balance and walking speed with Time Up and Go test
Time Frame: inclusion; 6 weeks; 12weeks; 9 months
Dynamic balance and walking speed. A shorter time means a better result
inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at 30-second Chair Stand Test
Time Frame: inclusion; 6 weeks; 12weeks; 9 months
Score at lower body strength. Higher scores mean a better outcome
inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at arm Curl Test
Time Frame: inclusion; 6 weeks; 12weeks; 9 months
Score at upper body strength. Higher scores mean a better outcome
inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at six Minutes' Walk Test (6MWT)
Time Frame: inclusion; 6 weeks; 12weeks; 9 months
Aerobic capacity. Higher distance traveled means a better result
inclusion; 6 weeks; 12weeks; 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Poitiers

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: David Clarys, University of Poitiers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 21, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAPR2021-2020-12021410

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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